For centuries, people have attempted to cure ailments and diseases with whatever means they had available at the time. Initially, this could include rituals or sacred procedures. As time progressed, people started to discover the efficacy of certain herbs, roots, and other naturally occurring substances in the treatment of ailments. As civilization progressed even further, science allowed for humans to discover what made the herbs and roots so effective. Useful and effective compounds were identified, isolated, purified, and administered with great efficacy in the treatment of diseases.
People then discovered they could actually create compounds, based both on knowledge gleaned from their past in combination with knowledge gained from scientific experimentation. With this new creative ability, diseases were fought on massive scales, and deaths as a result dropped drastically. As of now, two diseases were even fought to eradication, smallpox and rinderpest, and numerous other diseases are believed to be just a few years away from eradication. Yet, certain diseases are more difficult to treat, and some are even the result of an individual's behavior, so they cannot be eradicated purely through the use of treatment. In many cases, they must be fought as they appear in the individual.
Of particular importance is the human liver. The liver is has a myriad of functions in the body which comprises cleaning toxins from blood, regulating bodily functions, producing substances for proper digestion, producing regulatory signal molecules, and even facilitating blood clotting. The liver also has the unique ability to function even if a significant portion has been removed. However, with the myriad of functions performed by the liver, there are also a myriad of ailments which may affect the liver and its ability to function.
There are a myriad of ailments that may be experienced due problems in the liver which comprises cancer, cirrhosis, primary sclerosing, cholangitis, cholelithiasis, non-alcoholic fatty liver disease, non-alcoholic steatohepatitis, high cholesterol, cardiovascular conditions and diabetes. Various medicines and treatments have been created in order to combat these conditions, but they experience similar issues as other medicines and treatments. Through diligent research and enormous efforts, many useful molecules have been and are being discovered. This may have resulted in a double edged sword, as now there are a voluminous amount of useful molecules or suspected useful molecules, but as a consequence, there are virtually an infinite number of combinations using these molecules. Certain molecules or drugs have beneficial effects when combined with other molecules, but without going through rigorous experimentation, often including costly and expensive human trials, many of these combinations are, and will remain, undiscovered. The problem with combining molecules, however, is that the results can be hard to predict, and in many cases can cause more harm than good. Many drugs may be used subsequently without disastrous side-effects, but concurrently taking an effective dose of that same drug can result in serious side-effects, including death. As a result, experimentation must be done slowly and deliberately which may result in discovering non-useful formulations. The cost and danger associated with experimentally combining different drugs in a patient can be both extremely costly, and more importantly, extremely dangerous.
Further, although it is known that combining different molecules in a single drug treatment compound is theoretically possible, it is not possible to predict with certainty what the combination may do. Because there are a multitude of biochemical pathways in the body, most experiments are done in vitro under conditions that the experimenter believes may be relevant. Once data is acquired, and there is some level of confidence in what the compound actually does, experiments with live patients or other organisms may be started. However, due to the complexity of a fully functioning host, the compound may interfere or react with pathways wholly unaccounted for in the in vitro trials. Even though two molecules appear to act on different biochemical pathways, it is possible that, in combination, they will wholly inhibit a completely different pathway, whereas, when alone, they would only inhibit one part of the pathway which the body could compensate for by using an alternate pathway. Thereby, the pathway in danger of being shut down would be undetected until the two drugs are used in conjunction.
Even with all the medication at our disposal, patients are fighting and living with cancer and other liver ailments, often for the rest of their lives. Often, the drugs are simply not effective enough to cure the cancer or the ailment completely and finding methods of combining drugs to increase effectiveness is extremely slow, costly, difficult, and often fruitless work.
Chinese Patent Application Publication No. 102225961A discloses a molecule comprising berberine and ursodeoxycholic acid with a linker of indeterminate length. This reference broadly states that the compound is useful for treating tumors, but this reference lacks instructive information or specific details that would be critical in determining the utility of the molecule, and a person of ordinary skill in the art would not reasonably consider this reference when designing molecules to combat specific forms of cancer due to its lack of information and data. Additionally, the tumors referenced could relate to non-cancerous tumors. The reference does not even provide any data that the disclosed molecule is, in fact, effective at anything it claims. The reference merely discloses generic molecules that may be used as carrier molecules. It is likely that even slightly different configurations of the molecule disclosed by the reference would have vastly different effects, or even no effects at all. Additionally, it is generally understood that a molecule can have vastly different effects on different medical conditions, even where the medical conditions appear to be somewhat related. Thus, even in light of this reference, a person of ordinary skill in the art would not be able to determine the usefulness, if any, of a molecule comprising berberine and ursodeoxycholic acid or effectively use any of the disclosed information to create liver cancer treatment methods.
Thus, there exists the need for effective methods and compounds for treating cancer and other liver ailments.